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| ID | Type | Description | Link |
|---|---|---|---|
| 12591 | Other Identifier | Ministry of Food and Drug Safety |
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The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).
This study is to see the regression rate of Cervical Intraepithelial Neoplasia (CIN3) and to see the inducement of Cytotoxic T Lymphocyte.
The First treatment group will be administered with BLS-ILB-E710c 500mg for 8 weeks followed by 1 week observation The Second treatment group will be administered with BLS-ILB-E710c 1000mg for 8 weeks followed by 1 week observation The Third treatment group will be administered with BLS-ILB-E710c 1500mg for 8 weeks followed by 1 week observation The fourth treatment group will be administered with BLS-ILB-E710c Optimum dose for 8 weeks followed by 8 weeks observation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLS_ILB_E710c 500mg | Experimental |
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| BLS_ILS_E710c 1000mg | Experimental |
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| BLS_ILS_E710c 1500mg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLS_ILS_E710c 500mg | Drug | - 2 capsules per day for 20 days (week 1,2,4 & 8) |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 : Safety | Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0 | up to 9 weeks |
| Phase 2a : Regression rate | Regression rate will be assessed at the time of screening and 9 weeks(option), 16 weeks. Regression means the change from the stage of CIN1 to normal | screening and 9 weeks(option), 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Reid Colposcopic Index | Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9. | Phase 1 : up to 9 weeks |
| Reid Colposcopic Index | Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Kwan Lee, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| Tae Jin Kim, MD, PhD | Kwandong University College of Medicine Cheil Hospital | Principal Investigator |
| Jong Sup Park, MD, PhD | The Catholic University, Korea Seoul St Mary's Hospital | Principal Investigator |
| Chi-Heum Cho, MD, PhD | The Dongsan Medical Center of Keimyung University | Principal Investigator |
| Jong Hyeok Kim, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | Seoul | 152-703 | South Korea | ||
| The Dongsan Medical Center of Keimyung University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31576684 | Derived | Park YC, Ouh YT, Sung MH, Park HG, Kim TJ, Cho CH, Park JS, Lee JK. A phase 1/2a, dose-escalation, safety and preliminary efficacy study of oral therapeutic vaccine in subjects with cervical intraepithelial neoplasia 3. J Gynecol Oncol. 2019 Nov;30(6):e88. doi: 10.3802/jgo.2019.30.e88. |
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| BLS_ILB_710c 1000mg | Drug | - 4 capsules per day for 20 days (week 1,2,4 & 8) |
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| BLS_ILS_E710c 1500mg | Drug | - 6 capsules per day for 8 weeks (week 1,2,4 & 8) |
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| Phase 2a : up to 16 weeks |
| Serum anti-E7 antibody | Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks. | 1 week, 9 weeks, 16 weeks |
| Daegu |
| 700-712 |
| South Korea |
| Kwandong University College of Medicine Cheil Hospital | Seoul | 100-380 | South Korea |
| The Catholic University, Korea Seoul St Mary's Hospital | Seoul | 137-701 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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